BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOLUMEVIEW FEMORAL CATHETER KIT

    MDR report key: 17277124 · Received July 7, 2023

    Report

    Report Number
    2015691-2023-14406
    Event Type
    Malfunction
    Date Received
    July 7, 2023
    Date of Event
    June 5, 2023
    Report Date
    August 16, 2023
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    LFK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING RECORDS WERE REVIEWED AND THERE IS NO INDICATION OF A RELATED NONCONFORMANCE. ALL PROCESS PARAMETERS WERE MET AND INSPECTIONS PASSED SUCCESSFULLY. BASED ON FURTHER ENGINEERING EVALUATION, AS PART OF THE MANUFACTURING PROCESS THE GUIDEWIRE INSPECTION IS PERFORMED. ADDITIONALLY, A VISUAL AND DIMENSIONAL INSPECTION PROCESS IS PERFORMED TO THE THE PURCHASED DILATORS AS PART OF THE INCOMING INSERTION PROCESS. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW.

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED FOR EVALUATION; IT WAS DISCARDED AT THE HOSPITAL. WITHOUT THE RETURN OF THE PRODUCT, IT IS NOT POSSIBLE TO DETERMINE IF DAMAGES OR DEFECTS EXISTED ON THE PRODUCT, NOR COULD A ROOT CAUSE OR POTENTIAL CONTRIBUTING FACTORS BE IDENTIFIED.

    Description of Event or Problem · 0

    AS REPORTED, DURING INSERTION OF THE FEMORAL ARTERY CATHETER OF THIS VOLUME VIEW SET (MEDWATCH 32833), USER FELT RESISTANCE WHEN INTRODUCING THE GUIDEWIRE. IT WAS REMOVED WITHOUT PROBLEMS AND A NEW GUIDEWIRE FROM A NEW VOLUME VIEW KIT (MEDWATCH 32834) WAS TRIED TO BE INSERTED IN THE FEMORAL ARTERY IN THE OTHER LEG. HOWEVER, RESISTANCE WAS FELT AGAIN, AND THIS SECOND GUIDEWIRE GOT STUCK. VASCULAR SURGEON WAS CALLED TO REMOVE THE DEVICE BY A PERCUTANEOUS INTERVENTION. UPON REMOVAL, THE GUIDEWIRE WAS FOUND FRAYED. PATIENT DIED SOME DAYS AFTER FOR UNKNOWN AND UNRELATED CAUSE TO THIS EVENT. THE DEVICES WERE AVAILABLE FOR EVALUATION. AS A SUMMARY TWO MEDWATCH REPORTS WILL BE SUBMITTED, ONE FOR EACH DEVICE (32833 AND 32834).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498106 VOLUMEVIEW FEMORAL CATHETER KIT CATHETER FEMORAL LFK EDWARDS LIFESCIENCES, PR VLVFC5205 64292650

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Male